Body vessels, such as veins, arteries and other vessels, are prone to a variety of disorders and conditions for which modification of the luminal profile of the body vessel presents an opportunity for treatment. For example, the veins of the lower extremities contain venous valves that prevent blood from regurgitating back down the leg and help return blood to the heart. Each of these venous valves contains leaflets that coapt to provide valving action. Chronic Venous Insufficiency (CVI) can develop when one or more venous valves become incompetent, which can occur as a result of leaflets failing to coapt sufficiently. Once CVI develops, venous blood can pool in the lower leg, causing edema, varicose veins, pain and poor circulation.
Vein stripping and removal can be performed as treatment for venous insufficiency that occurs in superficial veins. For deep veins, however, the current standard treatment requires surgical intervention, such as valvuloplasty, vein transplantation or vein transposition.
Modifying the luminal profile of the body vessel at the location of an incompetent valve can increase or restore coaptation of leaflets in the valve. For example, if a body vessel has stretched or lost an ability to maintain valve leaflets in relative positions suitable for coaptation, a treatment that modifies the luminal profile of the body vessel can place the valve leaflets in relative positions suitable for coaptation to effectively restore valve function.
In one approach to modifying the luminal profile of a body vessel, referred to as ‘bulking,’ an agent is introduced into the layers of the wall of the body vessel. For example, U.S. Pat. No. 8,834,351 for METHOD OF MODIFYING VASCULAR VESSEL WALLS describes a bulking process in which a remodelable biomaterial is introduced into a wall of a body vessel of a patient's vasculature from a position within the lumen of the body vessel.
Modifying the luminal profile of an artery may prove beneficial in the treatment of arterial aneurysms and in the introduction of selective embolization. For example, modifying the luminal profile of an artery could be performed to reinforce the vessel wall of the artery at or near the site of an aneurysm. Also, modifying the luminal profile of an artery could be performed to a sufficient degree to achieve occlusion. This may provide a viable method for blocking blood flow to tumors or other cancerous regions.
Introducing a bulking agent to modify the luminal profile of a body vessel has proven challenging, though, and the art lacks specific methods and devices useful for accomplishing this promising, but delicate, treatment procedure. A need exists, therefore, for new and useful methods, medical devices and kits for modifying the luminal profile of a body vessel.